Kornimate/medical-research-clean huggingface dataset:
comparison of emergence delirium: remimazolam vs sevoflurane anesthesia

Conditions: Emergence Delirium

Summary: emergence delirium can lead to a range of clinical problems and is even associated with short-term behavioral changes in children. pediatric ear, nose, and throat (ent) surgery is one of the most common surgical types for postoperative delirium in children. sevoflurane anesthesia is also a known cause of postoperative delirium. therefore, this study aims to explore whether there is a difference in the incidence of postoperative delirium in children under remimazolam general anesthesia and sevoflurane anesthesia.

children aged 3-6 years old were randomly and equally allocated into two groups: group r remimazolam, group s with sevoflurane, respectively.

Eligibility criteria:
inclusion criteria: 1. age 3-6 years; 2. american society of anaesthesiologist (asa) i or ii; 3. booked for tonsillectomy and adenoidectomy; 4. bmi for age between the 25th and 85th percentiles according to the 2000 centers for disease control and prevention (cdc) growth charts. exclusion criteria: 1. children (asa iii- iv) who had abnormal liver and kidney function, cardiovascular, endocrine dysfunction, or any other organ dysfunction; 2. allergy or hypersensitive reaction to remimazolam; 3. mental disorder 4. recently respiratory infection; 5. other reasons that researchers hold it is not appropriate to participate in this trial: under specialized care or lived in social welfare institutions, or any other factors that could affect their ability to participate in the study.
pulse oximetry performance comparison in newborns

Conditions: Newborn; Birth, Preterm

Summary: the overall purpose is to directly compare pulse rate (pr) acquisition and oxygen saturation performance between two pulse oximeters (po) in newborns.


Eligibility criteria:
inclusion criteria: * parent or legal guardian is willing and able to provide informed consent prior to any study procedures being performed. * subject is expected to be able to participate for the duration of the evaluation in the delivery room. in most instances, the length of the study will not exceed the anticipated duration of ecg monitoring. * subject is ≥ 29 weeks gestational age. * subject can accommodate multiple sensors. exclusion criteria: * subjects that have an existing health condition, in which the investigator determines that safe or accurate oximetry measures may not be obtained at the areas where the po sensor could be placed. for example, major congenital anomalies, limb anomalies or anyone with abrasions or surface lesions on the contact areas would be excluded. * any subject whose treatment or condition would be compromised if they were to participate in this study and any patient whose use of a pulse oximeter and sensor would present a potential for serious risk to health, safety, or welfare. * currently participating in any other study expected to confound study results in the opinion of the investigator.
effect of preoperative intravenous dexamethasone on postoperative pain after primary total hip arthroplasty

Conditions: Localized Primary Osteoarthritis of Both Hips (Diagnosis); Osteoarthritis, Hip

Summary: to compare the effects of preoperative intravenous dexamethasone between 10 mg and 40 mg with placebo on postoperative pain after primary total hip arthroplasty

it still unclear whether the effective dose preoperative intravenous dexamethasone on postoperative pain after total hip arthroplasty. the research hypothesis is that the effect of 10 mg intravenous dexamethasone in postoperative pain(5 metre walking at 24 hour) is not inferior to 40 mg intravenous dexamethasone

Eligibility criteria:
inclusion criteria: * age \> 18 years * undergoing elective, primary, unilateral total hip arthroplasty * american society of anesthesiology (asa) physical class 1-3 * bmi \< 40 kg/m2 exclusion criteria: * history of previous musculoskeletal injury on the same hip * history of prior surgery on the same unilateral hip * history of adverse effects from medication utilized in this study * contraindication to spinal anesthesia * history of psychiatric disorders or cognitive impairment * contraindication to corticosteroid * poorly controlled diabetes mellitus * history of ischemic heart disease or peripheral arterial disease or cerebrovascular disease * hepatic insufficiency (child-pugh score \> 5) * renal insufficiency (creatinine clearance \< 30 ml/min) * history of cataract or glaucoma or ocular hypertension
effect of zinc suplementation on serum hemosystein level in hemodialysis patients

Conditions: End Stage Renal Failure

Summary: the purpose of this study is to study the effect of zinc supplementation in end stage renal failure on hemocystein level.

hemocystein increased in end stage renal failure and zinc involved in hemocystein metabolism thus zinc supplementation may be effective on hemocystein level.

Eligibility criteria:
inclusion criteria: * hemodialysis for 3 months * older than 18 years old * serum level of zinc less than 72.6 microgram/ l in men and less than 70 microgram/ l in female exclusion criteria: * acute renal failre * malabsorption * history of steroid or cytotoxic consumption

Keywords: hemocystein zinc renal failure
evaluation of transfer kinematics and kinetics in patients chronic post-stroke using the tibion bionic leg

Conditions: Stroke

Summary: the objective of this clinical study is to examine the acute kinematics and kinetics of utilizing the tibion bionic leg in a sample of chronic post-stroke patients performing sit-to-stand and stand-to-sit transfers across a range of assistance and resistance settings (internal to the device); to compare these metrics to baseline performance without the bionic leg; and to determine the bionic leg settings that optimize a restorative (equal force distribution) movement state in these patients.

comprehensive motion (kinetics and kinematics) data specific to sit-to-stand and stand-to-sit transfers with and without the tibion bionic leg. the vicon motion analysis system will be utilized to track movement using markers on the subject and the bionic leg per the ucsf human performance center's routine. once outfitted with the marker system, patients will be instructed to perform multiple sit-to-stand and stand-to-sit transfers while data is gathered. the sit-to-stand and stand-to-sit transfers will be performed using a standard chair, with a seat height not less than 12" from the floor. the chair will be positioned such that, at sitting rest, each of the subject's feet are positioned on limb-specific force plates (left and right).

Eligibility criteria:
inclusion criteria: * single ischemic stroke with residual unilateral lower-extremity weakness * chronic post-stroke (\>12 months since event) * eligible to participate to lower extremity physical therapy * age 30 years or greater * able to ambulate at least 10 meters without therapist assistance * able to ambulate without a leg brace * able to transfer from sitting to standing without physical assistance from a therapist * able to transfer from standing to sitting without physical assistance from a therapist * subject must understand the nature of the study and provide written informed consent prior to enrollment. * subject must be willing and able to attend all study sessions exclusion criteria: * medically unstable * age younger than 30 years * subacute post-stroke (\< 12 months since event) * status-post multiple strokes * status-post traumatic brain injury * not eligible to participate in lower extremity physical therapy * concomitant degenerative neurological conditions * not able to ambulate at least 10 meters without therapist assistance * unable to ambulate without a leg brace * unable to transfer from sitting to standing without physical assistance from a therapist * unable to transfer from standing to sitting without physical assistance from a therapist * unable to follow instructions, complete follow-up, or provide informed consent. * currently enrolled in another investigational device or drug trial

Keywords: stroke tibion bionics rehab therapy robotics intention
effect of specific versus general hamstring stretch on clinical outcomes in patellofemoral pain syndrome (pfps)

Conditions: Hamstring Shortness; Patellofemoral Pain Syndrome; Hamstring Flexibility; Patellofemoral Pain (PFPS)

Summary: this randomized, single-blind, parallel-group trial will compare the effects of three hamstring stretching interventions-general hamstring muscle energy technique (met), medial hamstring met, and lateral hamstring met-each combined with standardized tens and progressive hip/knee strengthening, on hamstring flexibility (knee-extension rom), anterior knee pain (arabic kujala score), pain intensity visual analogue scale (vas), and lower-limb strength (hand-held dynamometer) in adults with patellofemoral pain syndrome (pfps).

patients with chronic pfps will be randomized (1:1:1) into: general met group: standard non-specific hamstring met stretch medial met group: targeted medial-hamstring met stretch lateral met group: targeted lateral-hamstring met stretch all groups receive: tens: 20 min asymmetric biphasic square-pulse, 120 μs pulse width, 180 hz, electrodes around patella (5-7 cm apart) strengthening: 3×/week for 4 weeks; hip/knee exercises, start 3×10 reps → 3×20, progress with weights or resistance bands. outcomes are measured pre-intervention and at 4 weeks. analysis by mixed-design manova (α \< 0.05).

Eligibility criteria:
inclusion criteria: * anterior or retropatellar knee pain lasting at least three months * pain reproduced by at least two functional tasks: squatting, kneeling, prolonged sitting, stair climbing, hopping or running * pain intensity of ≥3 on a visual analog scale * positive active knee extension test (inability to achieve greater than 160° of knee extension with the hip at 90° of flexion) * body mass index (bmi) \ 18kg/m² exclusion criteria: * previous knee surgery * history of knee pathologies, such as meniscal injury' ligament injury, or knee osteoarthritis * psychological, cardiovascular' or neurological disorders * dizziness or fainting while doing exercises, pregnancy, or any contraindications to exercise * physical therapy treatment in the last 3 months

Keywords: patellofemoral pain syndrome pfps hamstring flexibility active knee extension test medial hamstring lateral hamstring specific hamstring stretch muscle energy technique tens visual analogue scale hand held dynamometer (hhd) kujala score
artificial intelligence for early detection of peripheral artery disease

Conditions: Peripheral Arterial Disease

Summary: the goal of this clinical trial is to test an ai-based screening tool that will help to identify patients at high risk of having undiagnosed peripheral artery disease. the primary outcome measure is overall rate of new pad diagnoses. secondary outcomes include rate of new secondary prevention measures initiated for pad, which will include new prescriptions for antiplatelets, pad-dosed rivaroxaban, statins, smoking cessation counseling or referrals, and/or supervised exercise therapy referrals also aggregated at a clinic and site level.

after providers consent to participate in this study, a screening tool will be deployed for their weekly clinics to identify patients at high risk of having undiagnosed pad. these high risk alerts will be provided after a patient has checked in for their outpatient appointment. the alert will be sent to their treating provider once the visit is initiated in the electronic health record system (ehr). the primary outcome measure is overall rate of new pad diagnoses. secondary outcomes include rate of new secondary prevention measures initiated for pad, which will include new prescriptions for antiplatelets, pad-dosed rivaroxaban, statins, smoking cessation counseling or referrals, and/or supervised exercise therapy referrals also aggregated at a clinic and site level. for secondary analysis we will specifically evaluate patients who generated an alert and assess how patient demographics and/or clinical factors are associated with likelihood of abi testing, rate of abnormal abis (i.e. true positive rate), and subsequent initiation of secondary prevention measures. uc san diego health (ucsdh), va san diego health care (vasdhc), and stanford health care (shc) will be the sites for study enrollment. ucsdh - la jolla campus, ucsdh - hillcrest campus, and vasdhc will begin a pre-intervention observation period at the same time, and then each site will be randomized to begin screening tool intervention in a stepped wedge pattern at 13-week intervals for a total of 52 weeks. we will enroll 10 clinics per site based on power calculations for number of patients needed to screen each week and to minimize the number of alerts per clinic/ provider. after this 52 week period, the stanford site will serve as a validation site and will undergo randomization of 10 clinical sites to three 13 week intervals for a total of 52 weeks.

Eligibility criteria:
inclusion criteria: * aged 50-85 years * presenting to an outpatient appointment at ucsdh, sdva, or shc * no previous diagnosis of pad * no prior pad alert triggered for a previous visit exclusion criteria: * \ 85 years of age * prior diagnosis of pad

Keywords: peripheral arterial disease
evaluation and risk assessment for persistent postsurgical pain after breast surgery

Conditions: Breast Cancer; Chronic Pain; Acute Pain; Depression, Anxiety

Summary: pre-existing pain and severe postoperative pain are predictors of persistent pain after surgery, but a complete understanding on the development of persistent pain is still lacking. the study aims to identify clinically relevant and genetic risk factors for persistent postsurgical pain that can be reliably distinguished statistically.

the study will focus on: (i) risk factors representing biopsychosocial processes that influence chronic pain, such as pain and psychological vulnerability; (ii) genetic factors relating to mechanistic pathways to persistent pain generation. patients will be recruited from those undergoing breast cancer surgery at the mentioned site. pain and anxiety assessment will be conducted via visual analogue scoring, mechanical temporal summation assessment and a series of questionnaires. after the surgery, all patients will be given appropriate analgesia, and the pain score and analgesia usage will be recorded. phone survey will be conducted 4 and 6 months, respectively, after surgery to determine the outcomes.

Eligibility criteria:
inclusion criteria: * aged between 21 - 80 year old; * healthy and/or have systemic medical conditions as reviewed by anaesthetist for surgery (asa 1-3); * undergoing breast cancer surgery. exclusion criteria: * history of intravenous drug or opioid abuse; * current chronic daily treatment with corticosteroids (excluding inhaled steroids); * previous history of chronic pain syndrome; * obstetric patients.

Keywords: breast cancer chronic pain acute pain depression anxiety
tocilizumab and atezolizumab in adults with locally advanced or metastatic non-small cell lung cancer refractory to 1st line immune checkpoint inhibitor-based therapy

Conditions: Lung Cancer, Nonsmall Cell

Summary: this is a research study to evaluate the safety and effectiveness of tocilizumab in combination with atezolizumab to treat non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * advanced non-squamous nsclc (stage iv or recurrent after initial curative intent therapy) in adults age 18 or older * prior exposure to at least 1 line of therapy * exposure to a including checkpoint inhibitor in line of therapy immediately prior to enrollment on trial * ecog ps 0-2 exclusion criteria: * presence of a driver mutation that is susceptible to targeted therapy * no greater than ctcae v5 grade 3 toxicity attributed to prior immunotherapy * other active invasive malignancy requiring ongoing therapy * evidence of progressing or untreated brain metastases * evidence or history of leptomeningeal disease * uncontrolled tumor related pain * history of an autoimmune disease or ipf
intervention for veterans with depression, substance disorder, and trauma

Conditions: Depressive Symptoms; Substance-related Disorders; Posttraumatic Stress Disorders

Summary: this study will compare two different types of psychotherapy for veterans with depression, addiction, and a past traumatic experience. everyone in the study will receive 12 weeks of group cognitive behavioral therapy focused on depression and addiction, followed by 12 weeks of individual psychotherapy sessions. for the second 12 weeks, half of the people will receive a review of the initial therapy, and half will receive a cognitive behavioral therapy focused on trauma. everyone will complete research interviews every 3 months for a total of 18 months.

the goal of this study is to evaluate whether a second disorder-specific intervention improves longer term (up to 18 months) treatment outcomes for male and female veterans with co-occurring depression and alcohol/substance disorders and trauma history (with or without ptsd diagnosis). this 4 years randomized two-group design uses repeated assessments at baseline and every 3 months for a total of 12 months. the investigators are providing their recently developed integrated intervention for comorbid depression and substance disorders for the initial 12 weeks in group format (integrated cognitive behavioral therapy; phase i). after the 12 week group intervention, participants will be randomized to receive either a review of the initial intervention in individual sessions, or a trauma-specific intervention, cognitive processing therapy, with integrated addiction treatment components. length, duration, and setting of both interventions will be the same, and all participants will meet with the program psychiatrist for medication appointments. no medications are under study and no placebo is used; medications will be prescribed using standard va protocol. research assessments will document diagnosis, recent substance use, depression and ptsd symptoms, medication adherence, and life stress.

Eligibility criteria:
inclusion criteria: * veterans 18 years of age and older living in the san diego, california area * who are able to attend in-person therapy sessions * have depression, alcohol or substance addiction, and a past traumatic experience exclusion criteria: * non-veterans * individuals with schizophrenia or severe memory impairment

Keywords: depressive symptoms substance-related disorders posttraumatic stress disorders psychotherapy
a clinical trial of proton pump inhibitors to treat children with chronic otitis media with effusion

Conditions: Otitis Media With Effusion

Summary: this study is being done to see if reflux of stomach fluid might be a cause of chronic fluid in the ears. our hypothesis is that treatment with an anti-reflux medication (lansoprazole) will increase the rate of resolution of chronic middle ear fluid in children.

this study is being done to see if reflux of stomach fluid might be a cause of fluid in the ears. earlier studies have found pepsin or pepsinogen, a component of stomach fluid, in the middle ear fluid of many children with chronic middle ear fluid. anti-reflux medicines called proton pump inhibitors (ppi) reduce the acidity of the contents of the stomach and the activity of pepsin or pepsinogen. we are studying the effectiveness of a ppi called lansoprazole (prevacid™) in reducing fluid in the ears. if lansoprazole is able to reduce the fluid in the middle ear, this tells us that the reflux of gastric acid into the esophagus and into the ear canal may be causing middle ear fluid.

Eligibility criteria:
inclusion criteria: * history of chronic otitis media with effusion meeting clinical indications for tympanostomy tubes placement, defined as the presence of middle ear fluid on physical exam for at least 3 months, in at least one ear. exclusion criteria: * past medical history or concurrent conditions known to increase the incidence of either recurrent otitis media or otitis media with effusion or gastroesophageal reflux disease, including cleft palate, neurological delay, cerebral palsy, down syndrome, velocardiofacial syndrome, and primary ciliary dyskinesia. * children with structural abnormalities of the tympanic membranes, such as cholesteatoma, deep retraction pockets, and atelectasis of the tympanic membrane. these abnormalities would require placement of tympanostomy tubes in standard clinical practice. * children weighing less than 10 kilograms, due to the lower weight limit for standard prevacid™ dosing

Keywords: otitis media with effusion gastroesophageal reflux ear infection proton pump inhibitor
freestyle libre glucose monitoring system paediatric study

Conditions: Diabetes Mellitus

Summary: the study is designed to determine glycaemic control achieved using the freestyle libre flash glucose monitoring system (freestyle libre) versus self-monitoring blood glucose (smbg) for the self-management of diabetes.


Eligibility criteria:
inclusion criteria: * aged ≥4 years and ≤17 years. * has an identified caregiver of ≥18 years. * type 1 diabetes using insulin (administered by injections or csii) for at least 1 year. * current insulin regimen has been unchanged for at least 2 months prior to enrolment (e.g. change of insulin or administration method), with no plans to change insulin regimen. * currently testing bg, on average at least 2 times per day. exclusion criteria: * concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition. * currently prescribed oral steroid therapy for any acute or chronic condition (or requires it during the study). * currently receiving dialysis treatment or planning to receive dialysis during the study. * female participant known to be pregnant. * participating in another device or drug study that could affect glucose measurements or glucose management. * currently using or planning to use freestyle libre flash glucose monitoring system or a continuous glucose monitoring (cgm) device during the study. * has used the freestyle libre flash glucose monitoring system or a continuous glucose monitoring (cgm) device in the previous 3 months. * known (or suspected) allergy to medical grade adhesives. * in the investigator's opinion the participant is unsuitable to participate due to any other cause/reason (participant and caregiver considered).

Keywords: diabetes mellitus, paediatric sensing technology
observational study to evaluate the safety of levemir® in diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this observational study is conducted in north america. the aim of this observational study is to evaluate the incidence of adverse events while using levemir® under normal clinical practice conditions.


Eligibility criteria:
inclusion criteria: * type 1 or 2 diabetes * including newly diagnosed not on insulin or insulin analogue treatment * selection at the discretion of the physician * adult patients with type 1 and 2 diabetes mellitus, and type 1 patients 6 years and older exclusion criteria: * current treatment with levemir® * previously enrolled in the study * hypersensitivity to levemir®